A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 768
- 试验地点
- 129
- 主要终点
- Progression-Free Survival (PFS) by Central Review Assessment
研究概览
简要总结
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nintedanib (BIBF 1120) + BSC
干预措施: Nintedanib (BIBF 1120) (Drug)
Nintedanib (BIBF 1120) + BSC
干预措施: BSC (Drug)
Placebo + BSC
干预措施: Placebo (Drug)
Placebo + BSC
干预措施: BSC (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) by Central Review Assessment
时间窗: From randomisation until cut-off date 14JUN2016.
PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first. Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Overall Survival (OS)
时间窗: From randomisation until cut-off date 14JUN2016.
OS was defined as the time from randomisation to the time of death from any cause. Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
次要结局
- Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment(From randomisation until cut-off date 14JUN2016.)
- Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment(From randomisation until cut-off date 14JUN2016.)